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急性早幼粒细胞白血病中蒽环类药物联合化疗加或不加全反式维甲酸的比较。

Comparison of anthracycline-based combination chemotherapy with or without all-trans retinoic acid in acute promyelocytic leukemia.

作者信息

Raza Shahid, Ullah Khalil, Ahmed Parvez, Khan Badshah

机构信息

Department of Haematology, Armed Forces Bone Marrow Transplant Centre, Rawalpindi.

出版信息

J Coll Physicians Surg Pak. 2008 Sep;18(9):546-50.

PMID:18803891
Abstract

OBJECTIVE

To compare survival in Acute Promyelocytic Leukemia (APL) patients treated with or without All-Trans Retinoic Acid (ATRA).

STUDY DESIGN

Longitudinal, comparative study.

PLACE AND DURATION OF STUDY

The Armed Forces Bone Marrow Transplant Centre (AFBMTC), Rawalpindi, Pakistan from May 2001 to April 2007.

METHODOLOGY

All consecutive newly diagnosed patients of acute promyelocytic leukemia, treated at Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan, between May 2001 and April 2007, were included and given chemotherapy according to availability of ATRA. Diagnosis was confirmed on morphology/ karyotyping/ molecular analysis. Eligibility criteria included confirmed morphologic diagnosis and/or by demonstration of t(15;17) and/or PML/RAR proportional to re-arrangement, no prior chemotherapy, normal hepatic and renal function, Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and no contraindications to ATRA (history of sensitivity to Vit. A or other retinoids). All patients having history of cardiac failure (LVEF < 50) and arrhythmias, ECOG performance status 3 and 4, relapse / refractory disease, ALT twice normal values, serum creatinine > 150 micromol/L and pregnancy were excluded from this study. Survival was calculated from the date of chemotherapy to death or last follow-up according to Kaplan-Meier and Cox (Proportional hazard) regression analysis methods.

RESULTS

During the 6 years study period, 31 newly diagnosed patients with acute promyelocytic leukemia received treatment at AFBMTC. Seventeen patients received anthracycline-based remission induction and consolidation chemotherapy, while 14 received ATRA-based remission induction, consolidation and by two years maintenance therapy. Overall Survival (OS), Disease Free Survival (DFS) and mortality were 29.4%, 29.4% and 70.6% respectively in 17 patients who received anthracycline based chemotherapy, whereas in patients who received ATRA-based chemotherapy OS, DFS and mortality was 71.4%, 64.2% and 28.6% respectively. Major causes of mortality were septicemia and chemotherapy related toxicity.

CONCLUSION

Response to ATRA-based chemotherapy in patient cohort was better as compared with anthracycline based chemotherapy (71.4% vs. 29.4%) in terms of survival and mortality.

摘要

目的

比较接受或未接受全反式维甲酸(ATRA)治疗的急性早幼粒细胞白血病(APL)患者的生存率。

研究设计

纵向比较研究。

研究地点和时间

2001年5月至2007年4月在巴基斯坦拉瓦尔品第的武装部队骨髓移植中心(AFBMTC)。

方法

纳入2001年5月至2007年4月期间在巴基斯坦拉瓦尔品第武装部队骨髓移植中心接受治疗的所有连续新诊断的急性早幼粒细胞白血病患者,并根据ATRA的可获得情况给予化疗。通过形态学/核型分析/分子分析确诊。入选标准包括确诊的形态学诊断和/或通过显示t(15;17)和/或PML/RAR重排比例,无既往化疗史,肝肾功能正常,东部肿瘤协作组(ECOG)体能状态为0 - 2且无ATRA禁忌证(对维生素A或其他类视黄醇过敏史)。所有有心力衰竭病史(左心室射血分数<50)和心律失常、ECOG体能状态为3和4、复发/难治性疾病、谷丙转氨酶(ALT)高于正常值两倍、血清肌酐>150微摩尔/升及妊娠的患者均被排除在本研究之外。根据Kaplan-Meier和Cox(比例风险)回归分析方法计算从化疗开始至死亡或最后随访的生存率。

结果

在6年的研究期间,31例新诊断的急性早幼粒细胞白血病患者在AFBMTC接受治疗。17例患者接受了基于蒽环类药物的缓解诱导和巩固化疗,而14例患者接受了基于ATRA的缓解诱导、巩固及两年维持治疗。接受基于蒽环类药物化疗的17例患者的总生存率(OS)、无病生存率(DFS)和死亡率分别为29.4%、29.4%和70.6%,而接受基于ATRA化疗的患者的OS、DFS和死亡率分别为71.4%、64.2%和28.6%。主要死亡原因是败血症和化疗相关毒性。

结论

在生存率和死亡率方面,与基于蒽环类药物的化疗相比,该患者队列中基于ATRA的化疗反应更好(71.4%对29.4%)。

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